USPTO Patents Application 09981289

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria. Virginia 223 1 3-1450
■ww\v .uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

09/981,289

10/15/2001

7590 10/05/2004

FLEHR HOHBACH TEST
ALBRITTON & HERBERT LLP
Four Embarcadero Center, Suite 3400
San Francisco, CA 94111

Bassil I. Dahiyat

A-68990-3/RFT/RMS/RMK

5268

EXAMINER

SEHARASEYON, JEGATHEESAN

ART UNIT

PAPER NUMBER

1647

DATE MAILED: 10/05/2004

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

UTTICQ ACtlOn nummary

MppilGclIlun NO.

09/981 ,289

Annlir*antf

DAHIYAT ET AL.

Examiner

Jegatheesan Seharaseyon

Art Unit

1647

The MAILING DATE of this communication appears on the cover sheet with the correspondence address

Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 . 1 36(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1 )S Responsive to communication(s) filed on 25 June 2004 .
2a)Q This action is FINAL. 2b)S This action is non-final.

3) Q Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1 935 CD. 11, 453 O.G. 213.

Disposition of Claims

4) £3 Claim(s) 28-49 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) D Claim(s) is/are allowed.

6) H Claim(s) 28-49 is/are rejected.

7) D Claim(s) is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10)D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
1 !)□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12)Q Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f).
a)D All b)D Some * c)D None of:

1 Certified copies of the priority documents have been received.

2. D Certified copies of the priority documents have been received in Application No. .

3. Q Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) IS Notice of References Cited (PTO-892) 4) Q Interview Summary (PTO-413)

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948) Paper No(s)/Mail Date. .

3) El Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 5) □ Notice of Informal Patent Application (PTO-152)

Paper No(s)/Mail Date 6/25/2004 . 6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 1-04)

Office Action Summary

Part of Paper No./Mail Date 09092004

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Art Unit: 1647

DETAILED ACTION

1 . A request for continued examination under 37 CFR 1 .1 14, including the fee set forth
in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
application is eligible for continued examination under 37 CFR 1.114, and the fee set
forth in 37 CFR 1 .17(e) has been timely paid, the finality of the previous Office action
has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
6/25/2004 has been entered. An action on the RCE follows.

2. Claims 1-3 and 16-27 have been cancelled. Claims 29-49 have been added.
Therefore, Claims are 28-49 are pending.

3. The text of those sections of Title 35, U. S. Code not included in this action can be
found in a prior Office action.

4. The pending rejections of claims 1-3 and 13-27 are withdrawn because Applicant has
elected to cancel these pending claims. However, any remarks related to the newly
added claims will be addressed below as it applies to claims 28-49.

5. New claim rejections necessitated by Applicants amendments.

Claim Rejections - 35 USC §112

6. Claims 28-49 are rejected under 35 U.S.C. 112, second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject matter which
applicant regards as the invention.

6a. Claim 28 is rejected as vague and indefinite because it is unclear as to what
receptor if any signaling activation is affected by mixed trimers of TNF.

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6b. Claims 29-45 are rejected as vague and indefinite because the claims call for one or
more amino acid substitution compared to naturally occurring human TNF. However,
more than one amino acid change is not defined. It could potentially include amino acid
changes that include the functional motifs or entire TNF polypeptide and not resemble
the TNF functionally or structurally. Therefore, metes and bounds can't be determined.
Claims 30-35, 37-39, 41-42 and 44-45 and 47-49 are rejected insofar as they depend
on claims 29, 36, 40 and 43.

6c. Claims 29-49 are rejected as vague and indefinite because the claims call for at
least one amino acid substitution but do not require any conservation of structure or
function. Therefore, metes and bounds can't be determined. Claims 30-35, 37-39, 41-
42, 44-45 and 47-49 are rejected insofar as they depend on claims 29, 36, 40, 43 and
46.

7. The following is a quotation of the first paragraph of 35 U.S.C. 112:

The specification shall contain a written description of the invention, and of the manner and process of
making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
set forth the best mode contemplated by the inventor of carrying out his invention.

7a. Claims 37, 46-48 are rejected under 35 U.S.C. 112, first paragraph, as containing
subject matter which was not described in the specification in such a way as to
reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
application was filed, had possession of the claimed invention. This is a new matter
rejection.

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Art Unit: 1647

The newly introduced claims contain several amino acid substitutions (ex: Q21K,
N30E, R31 V, R31 L, R32H, R32T, A35T, G66N, G66R, G66E, A1 11 K, A1 1 1 D, Y1 1 5V,
D140Q, D140E, F144Q, F144H, E146D, E146Q, E146H, E146E, E146T and A84V) that
were not originally described. Although, Applicant asserts that there is support for these
substitutions in the specification and claims as originally filed, the Office cannot find
support these substitutions in the specification including Figure 7.

7b. Claim 28 is rejected under 35 U.S.C. 112, first paragraph, as containing subject
matter which was not described in the specification in such a way as to reasonably
convey to one skilled in the relevant art that the inventor(s), at the time the application
was filed, had possession of the claimed invention. This is a written description
rejection.

The specification discloses the nucleotides encoding a human TNF-ct (SEQ ID
NO: 2) and substitutions at wild-type positions 21 , 30, 31 , 32, 33, 35, 65, 66, 67, 1 1 1 ,
112, 115, 140 and 143 (Figure: 7). This meets the written description and enablement
provisions of 35 USC 112, first paragraph. However, the specification does not disclose
all variant TNF-a sequences with one or more amino acid substitution. Absent a
comparison sequence, additional variants encompassed have not been set forth in the
instant specification. The claim as written, however, encompass variant TNF-a
sequences which were not originally described and fail to meet the written description
provision of 35 USC 112, first paragraph because the written description is not
commensurate in scope with the recitation of claim 28. In the instant claims non-

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naturally occurring variant sequence is compared to a naturally occurring human TNF-a.
There is no description of all naturally occurring human TNF-a. This is due to the fact
that the allelic variant sequence is an alternative form of the gene that may result from
at least one mutation in the nucleic acid sequence. Alleles may result in altered mRNAs
or polypeptides whose structure or function may or may not be altered. Any given gene
may have none, one, or many allelic forms. Common mutational changes, which give
rise to alleles, are generally ascribed to natural deletions, additions, or substitutions of
nucleotides. However, claim recites at least one amino acid substitution in the TNF-a
polypeptide. Thus, the specification does not provide written description to support the
genus encompassed by the instant claims. In addition, specification fails to describe the
maximum number of possible changes to the human TNF-a and yet retain the TNF-a
activity.

Vas-Cath Inc. v. Mahurkar, 1 9 USPQ2d 1111, makes clear that "applicant must
convey with reasonable clarity to those skilled in the art that, as of the filing date sought,
he or she was in possession of the invention. The invention is, for purposes of the
'written description' inquiry, whatever is now claimed" (See page 1117.) The
specification does not "clearly allow persons of ordinary skill in the art to recognize that
[he or she] invented what is claimed" (See Vas-Cath at page 1116).

With the exception of isolated polynucleotide encoding the TNF-a polypeptide of

SEQ ID NO: 2 comprising substitutions at wild-type positions 21, 30, 31, 32, 33, 35, 65,

66, 67, 111, 112, 115, 140 and 143, the skilled artisan cannot envision all the detailed

chemical structure of the claimed nucleotide sequences of the variants, regardless of

the complexity or simplicity of the method of isolation.

Adequate written description requires more than a mere statement that it is part
of the invention and reference to a potential method for isolating it. The polypeptide

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itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen
Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what
one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes v.
Baird, claims directed to mammalian FGF's were found unpatentable due to lack of
written description for the broad class.

Therefore, only the isolated polynucleotide encoding the TNF-oc polypeptide of
SEQ ID NO: 2 with substitutions at wild-type Dositions 21, 30, 31, 32, 33, 35, 65, 66, 67,
84, 111, 112, 115, 140 and 143, but not the full breadth of the claims meets the written
description provision of 35 USC 112, first paragraph. The species specifically disclosed
are not representative of the genus because the genus is highly variant. As a result, it
does not appear that the inventors were in possession of various polypeptide
sequences set forth in claim 28.

Applicant is reminded that Vas-Cath makes clear that the written description
provision of 35 USC 1 12 is severable from its enablement provision. (See page 1115.)
Applicants are directed to the Revised Interim Guidelines for the Examination of Patent
Applications Under the 35 U.S.C. 112, U 1 'Written Description" Requirement, Federal
Register, Vol. 64, No. 244, pages 71427-71440, Tuesday December 21, 1999.

7c. Claims 29-45 are rejected under 35 U.S.C. 112, first paragraph, as containing
subject matter which was not described in the specification in such a way as to
reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
application was filed, had possession of the claimed invention. This is a written
description rejection.

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Art Unit: 1647

The specification discloses the nucleotides encoding a human TNF-a (SEQ ID
NO: 2) and substitutions at wild-type positions 21, 30, 31, 32, 33, 35, 65, 66, 67, 11 1,
1 12, 1 15, 140, 143, 144, 145, 146 and 147 (Figure: 7). Also described are the double
mutants K65E/D143K, K65E/D143R, K65D/D143K and K65D/143R. The specification
also discloses changes at positions K1 12D, Y1 15T, D143K, D143R and Y1 151. Further,
it is asserted that these changes maybe may be done either individually or in
combination, with any combination being possible (paragraph 0139). This meets the
written description and enablement provisions of 35 USC 112, first paragraph. Preferred
embodiments are asserted to utilize at least 1 to 5 changes, and preferably more,
positions in each variant TNF-a. However, the specification does not disclose all variant
TNF-a sequences with one or more amino acid substitution. The claims as written,
however, encompass variant TNF-a sequences which were not originally described and
fail to meet the written description provision of 35 USC 112, first paragraph because the
written description is not commensurate in scope with the recitation of claims 29-45.

Although, Applicant asserts in their response of 6/25/2004, that the specification
recites more than 70 variant TNF-a proteins, none of these mutations contain more than
2 amino acid changes. However, claims recite one or more amino acid substitution in
the TNF-a polypeptide. Thus, the specification does not provide written description to
support the genus encompassed by the instant claims. In addition, specification fails to
describe the maximum number of possible changes to the human TNF-a and yet retain
the TNF-a activity.

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With the exception of isolated polynucleotide encoding the TNF-a polypeptide of
SEQ ID NO: 2 with substitutions at wild-type positions 21 , 30, 31 , 32, 33, 35, 65, 66, 67,
111, 112, 115, 140, 143, 144, 145, 146, 147 the double mutant of 65/143 and changes
at 112, 115 and 143 alone or in combination, the skilled artisan cannot envision all the
detailed chemical structure of the claimed nucleotide sequences of the variants,
regardless of the complexity or simplicity of the method of isolation.

Therefore, only the isolated polynucleotide encoding the TNF-a polypeptide of
SEQ ID NO: 2 with substitutions at wild-type positions 21 , 30, 31 , 32, 33, 35, 65, 66, 67,
84, 111, 112, 115, 140, 143, 144, 145, 146, 147, the double mutant of 65/143 and
changes at 112, 1 15 and 143 alone or in combination, but not the full breadth of the
claims meets the written description provision of 35 USC 112, first paragraph. The
species specifically disclosed are not representative of the genus because the genus is
highly variant. As a result, it does not appear that the inventors were in possession of
the entire genus encompassing the various polypeptide sequences encompassed within
claims 29-45.

Applicant is reminded that Vas-Cath makes clear that the written description
provision of 35 USC 1 12 is severable from its enablement provision. (See page 1115.)
Applicants are directed to the Revised Interim Guidelines for the Examination of Patent
Applications Under the 35 U.S.C. 112, 1 'Written Description" Requirement, Federal
Register, Vol. 64, No. 244, pages 71427-71440, Tuesday December 21, 1999.

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7d. Claims 29-37 and 40-49 are rejected under 35 U.S.C. 112, first paragraph, because
the specification, while enabling for polynucleotides encoding TNF-a variants at
positions K112D, Y115T, D143K, D143R, Y115I, D143E, A145R, A145K, A145E,
E146K and E146R with respect to wild-type TNF-a of SEQ ID NO: 2 activities as
described in Figures 8, 9, 10a and 10b does not reasonably provide enablement for all
non-naturally occurring variants of TNF-a. Applicants in their response filed on
6/25/2004 correctly point out that the specification provides experimental data for 1 1
variant TNF-a sequences. However, this data only demonstrates the activity of single
amino acid substitution on TNF-a sequence and does not demonstrate multiple amino
acid substitutions. Further. Applicant contends that the antigenic profile of the variant
proteins should be similar to the wild-type protein. This will only be true provided that
there is no significant altering of surface residues. In addition, since only about six
residues are required to generate an antigenic epitope, as long there are six contiguous
residues that are similar in both the wild-type protein and the variant the antigenic profile
will be the same. Specifically, the specification fails to demonstrate any activity with
more than one amino acid substitution as compared to wild type human TNF-a of SEQ
ID NO: 2. Thus, the specification does not enable any person skilled in the art to which
it pertains, or with which it is most nearly connected, to make and use the invention
commensurate in scope with these claims.

The test of enablement is not whether any experimentation is necessary, but
whether, if experimentation is necessary, it is undue. See In re Wands, 858 F.2d at 737,
8 USPQ2d at 1404. The factors to be considered when determining whether there is

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sufficient evidence to support a determination that a disclosure does not satisfy the
enablement requirement and whether any necessary experimentation is "undue"
include, but are not limited to: (1 ) the breadth of the claims; (2) the nature of the
invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level
of predictability in the art; (6) the amount of direction provided by the inventor; (7) the
existence of working examples; and (8) the quantity of experimentation needed to make
or use the invention based on the content of the disclosure.

Despite knowledge in the art for producing non-naturally occurring variants of a
given polypeptide with amino acid deletions, insertions or substitutions the specification
fails to provide any guidance regarding the changes/modifications contemplated and yet
retain the function of the TNF-oc variants claimed. Furthermore, detailed information
regarding the structural and functional requirements of the disclosed protein is lacking.
Although it is accepted that the amino acid sequence of a polypeptide determines its
structural and functional properties, predicting a protein's structure and function from
mere sequence data remains an elusive task. The problem of predicting protein
structure from sequence data and in turn utilizing predicted structural determinations to
ascertain functional aspects of the protein is extremely complex. While it is known that
many amino acid substitutions are generally possible in any given protein the positions
within the protein's sequence where such amino acid substitutions can be made with a
reasonable expectation of success are limited. Certain positions in the sequence are
critical to the protein's structure/function relationship, e.g. such as various sites or
regions directly involved in binding, activity and in providing the correct three-

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dimensional spatial orientation of binding and active sites. These or other regions may
also be critical determinants of antigenicity. These regions can tolerate only relatively
conservative substitutions or no substitutions (see Wells, 1990, Biochemistry 29:8509-
8517; Ngo et al., 1994, The Protein Folding Problem and Tertiary Structure Prediction,
pp. 492-495, previously submitted with the Office Action of 10/22/2002). However,
Applicant has provided little or no guidance beyond the mere presentation of sequence
data to enable one of ordinary skill in the art to determine, without undue
experimentation, the positions in the protein which are tolerant to change (e.g. such as
by amino acid substitutions or deletions), and the nature and extent of changes that can
be made in these positions. Applicant has failed to demonstrate any activity with more
than one amino acid substitution as compared to wild type human TNF-a of SEQ ID
NO: 2.

Although the specification outlines art-recognized procedures for producing and
screening for active variants, this is not adequate guidance as to the nature of active
derivatives that may be constructed, but is merely an invitation to the artisan to use the
current invention as a starting point for further experimentation. Even if an active or
binding site were identified in the specification, they may not be sufficient, as the
ordinary artisan would immediately recognize that an active or binding site must assume
the proper three-dimensional configuration to be active, which conformation is
dependent upon surrounding residues; therefore substitution of non-essential residues
can often destroy activity. There is no description of the activity contemplated by the
changes contemplated by the Applicant. Therefore, predicting which nucleotide

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sequence encoding the non-naturally occurring variants would retain the functions of the
TNF-a protein is well outside the realm of routine experimentation. Thus, undue amount
of experimentation would be required to generate changes/modifications of the
nucleotides contemplated and yet retain the function of the non-naturally occurring
variant TNF-a proteins claimed.

Applicants have not taught how one of skill in the art would use the invention in a
manner commensurate in scope with the polynucleotide sequences encompassed by
the invention of claims 28-37 and 40-49. The specification as filed does not sufficiently
teach one of skill in the art how to make and/or use the full scope of the claimed
sequences. The amount of experimentation required to make and/or use the claimed
sequences would require trial and error experimentation to determine the functional
sequences. Given the breadth of claims 28-37 and 40-49 in light of the unpredictability
of the art as determined by the lack of working examples and shown by the prior at of
record, the level of skill of the artisan, and the lack of guidance provided in the instant
specification, it would require undue experimentation for one of ordinary skill in the art to
make and use the claimed invention.

7e. Claims 28 is rejected under 35 U.S.C. 112, first paragraph, because the
specification, while enabling for various activities described in Figures 8, 9, 10a and
10b, is not enabling for the activation of receptor signaling. Without guidance as to how
to test for activation receptor signaling, one of skill in the art would not know how to use
the instant invention.

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Claim Rejections - 35 USC § 102

8. Claims 28-37, 46, 48 and 49 remain rejected under 35 USC § 102(b) as being
anticipated by Banner et al. (U.S. Patent NO: 5, 597, 899) and as evidenced by Shin et
al. (U.S. Patent No. 5, 773, 582), for reasons set forth in Paper Nos: 13, 18 and 21.

As stated previously, the Office relied on the Banner reference to teach the
generation of the various TNF-alpha mutations with at least one amino acid substitution.
This reference teaches the preparation of mutations at several different amino acid
positions compared to the wild-type TNF-a, which has different binding affinity to p55-
TNF receptor compared to p75 TNF receptor. Using standard molecular biology
techniques (abstract). Amino acid substitutions have been made at 33, 34, 65, 67, 75,
143, 145 and 147, including the following changes: D143N, D143E, A145R and A145K
(abstract and Tables I and II). It also teaches generation of multiple amino acid
substitutions compared to wild-type TNF-a sequence, including at least 3 amino acid
substitutions (columns 5 and 6). Although Banner et al. may not have appreciated the
trimer formation itself nonetheless meets the limitations of the instant claims in the
teaching of the generation of various amino acid mutations. As noted previously in the
Office Action of 12/23/2003 the following evidentiary art of Shin et al. (U.S. Patent No. 5,
773, 582), human TNF -a is known to exist as a trimer with 3-fold axis of symmetry
(column 1, lines 64-67). Further the formation of mixed trimers is a consequence of
generating the TNF mutants described in the prior art because it is necessary to at least
have two different forms of TNF -a to generate the mixed trimers. Despite the fact that
applicants may have been the first to characterize the formation of mixed trimers, the

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formation of mixed trimers would inherently have occurred in the presence of the
teachings of Bennett et al. mutants, which are similar to those of the instant invention.
The mixed trimers will comprise either a single TNF mutein monomer or two TNF
mutein monomers or three TNF mutein monomers in combination with the naturally
occurring TNF monomer. In addition, these mutein monomers could be identical or
different. Therefore, Banner et al. anticipates variants that are capable of forming mixed
trimers, exchange with naturally occurring human- TNF -a and/or inactivate receptor
signaling because this activity is inherent to TNF receptors. Although, the Banner
reference teaches muteins with higher binding affinity and greater specificity for hp75-
TNF-R (column 3, lines1-5), it is silent on receptor signaling. Therefore, there is no
teaching away from the instant invention. In addition, Banner et al. also teaches
covalent modification of the muteins using polyethylene glycol (column 8, lines 5-18).

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The Examiner also notes the decision in Swinehart and Sfiligoj, 169 USPQ 226,
in which it was found that mere recitation of a newly discovered function or property,
inherently possessed by things in prior art, does not cause claim drawn to those things
to distinguish over prior art. Although the prior art did not necessarily appreciate the
mechanism of the formation of the mixed trimers comprising the TNF muteins, it clearly
teaches the same TNF-alpha mutants which are capable of forming the mixed trimers of
the instant invention. Thus, claims 28-37, 46, 48 and 49 remain rejected under 35 (JSC
§ 102 (b) as being anticipated by Banner et al. (U.S. Patent NO: 5, 597, 899).

Claim Rejections - 35 USC § 103
9. Claims 40-45 are rejected under 35 U.S.C. 103(a) as being unpatentable over
Banner et al. (U.S. Patent NO: 5, 597, 899) in view of Wallach et al. (U.S. Patent NO: 5,
695, 953).

The instant invention is drawn to glycosylated TNF -a muteins.

The teachings of Banner et al. (U.S. Patent NO: 5, 597, 899) has been described
above in paragraph 8. However, Banner et al. do not describe glycosylated TNF -a
muteins. Wallach et al. (U.S. Patent NO: 5, 695, 953) describe that proteins expressed
in mammalian cells such as human and CHO cells provide post-translational
modifications to protein including glycosylation (column 15, lines 24-28). Therefore, it
would have been obvious to one of ordinary skill in the art at the time the invention was
made to express the muteins disclosed in Banner et al. to generate the various
glycosylated TNF muteins of the instant invention as described by Wallach et al. One of
ordinary skill would have been motivated with reasonable expectation of success to

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generate muteins of Banner et al. that are glycsylated because variants of TNF-a
generated, form mixed trimers that make the TNF incapable of activating receptor
signaling or alter the biological activity of the mixed trimers. Therefore, the instant
invention is prima facie obvious over Banner et al. (U.S. Patent NO: 5, 597, 899) in
view of Wallach et al. (U.S. Patent NO: 5, 695, 953).

10. Applicant is advised that should claim 33 be found allowable, claim 34 will be
objected to under 37 CFR 1 .75 as being a substantial duplicate thereof. When two
claims in an application are duplicates or else are so close in content that they both
cover the same thing, despite a slight difference in wording, it is proper after allowing
one claim to object to the other as being a substantial duplicate of the allowed claim.
See MPEP § 706.03(k).

11. Claims 38, 39 and 47-49 if written independent of claim 36 and 46 will be allowable
over prior art. Claims 28-37 and 40-45 are not allowable over prior art.

Contact Information

Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Jegatheesan Seharaseyon whose telephone number is
571-272-0892. The examiner can normally be reached on M-F: 8:30-4:30.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Brenda Brumback can be reached on 571-272-0961. The fax phone
number for the organization where this application or proceeding is assigned is 703-
872-9306.

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Page 1 7

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JS 09/04

8RENDA BRUMBACK
SUPERVISORY PATENTEXAMWER
TECHNOLOGY CENTER 1600